Cervical CancerPhase 3NCT00128661

Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants

A Phase 3 study testing human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine and hepatitis A inactivated virus vaccine in people with Cervical Cancer and Precancerous Condition, run by GlaxoSmithKline at 1 site in Costa Rica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer, Precancerous Condition
What is being tested?: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine and hepatitis A inactivated virus vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7,466 participants
Where: 1 siteCosta Rica
Study dates: 30 Jun 2004to 31 Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
Women only
Healthy volunteers accepted
Adult

DISEASE CHARACTERISTICS:

•Healthy participants

Deemed to be in good general health by history and physical examination •Resident of Guanacaste Province of Costa Rica and surrounding areas
Must remain a resident for ≥ 6 months after the first study vaccination

PATIENT CHARACTERISTICS:

Age

18 to 25

Performance status

•Not specified

Life expectancy

•Not specified

Hematopoietic

•Not specified

Hepatic

No history of chronic hepatitis requiring treatment
No acute or chronic clinically significant hepatic function abnormality by physical examination or laboratory findings
No known history of hepatitis A infection

Renal

No history of kidney disease requiring treatment
No acute or chronic clinically significant kidney function abnormality by physical examination or laboratory findings

Cardiovascular

No acute or chronic clinically significant cardiovascular function abnormality by physical examination or laboratory findings Pulmonary
No acute or chronic clinically significant pulmonary function abnormality by physical examination or laboratory findings Immunology
No history of allergic disease
No history of autoimmune disorder requiring treatment
No history of allergic reaction (e.g., difficulty breathing) to any vaccine
No suspected allergy or reaction likely to be exacerbated by a component of the study vaccines (e.g., 2-phenoxyethanol or neomycin)
No hypersensitivity to latex
No diagnosis or suspicion of any immunodeficient condition by medical history or physical examination Other
Not pregnant or nursing ◦No delivery within the past 3 months
Negative pregnancy test
Fertile patients must use effective contraception for 30 days before, during, and for 60 days after completion of study treatment
Able to speak or understand Spanish
Mentally competent
Able to undergo pelvic exam (i.e., no heavy bleeding [menstruation or otherwise] or heavy vaginal discharge)
No history of cancer requiring treatment
No history of diabetes requiring treatment
No history of other chronic conditions requiring treatment
No acute or chronic clinically significant neurologic function abnormality by physical examination or laboratory findings
No other acute disease
No fever ≥ 37.5º C

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 6 months since prior chronic administration (i.e., > 14 days) of immune-modulating drugs
More than 90 days since prior immunoglobulins
More than 30 days since prior and no other concurrent investigational or non-registered vaccines
More than 30 days since prior registered vaccines
More than 8 days since prior routine meningococcal, hepatitis B, influenza, or diphtheria/tetanus vaccine
No prior vaccination against hepatitis A
No prior vaccination against human papillomavirus
No prior monophosphoryl lipid A or AS04 adjuvant

Chemotherapy

•Not specified

Endocrine therapy

More than 6 months since prior chronic administration (i.e., > 14 days) of corticosteroids (e.g., ≥ 0.5 mg/kg/day of prednisone or equivalent)
Concurrent inhaled or topical steroids allowed

Radiotherapy

•Not specified

Surgery

•No prior hysterectomy

Other

More than 6 months since prior chronic administration (i.e., > 14 days) of immunosuppressants
More than 30 days since prior and no other concurrent investigational or non-registered drugs

Trial locations and contacts

1 site in 1 country.

Costa Rica1 site

Proyecto Epidemiologico Guanacaste
Liberia

Other trials in Costa Rica

About this study

Official title: A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.

PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.

Read the detailed description

OBJECTIVES:

Primary

•Demonstrate the efficacy of the candidate vaccine, human papillomavirus 16/18 (HPV 16/18) L1 virus-like particle (VLP)/AS04 vaccine compared with control in preventing grade 2 or 3 cervical intraepithelial neoplasia, adenocarcinoma in situ of the cervix, or invasive cervical cancer (CIN2+) associated with HPV 16 or HPV 18 cervical infection in younger healthy participants who are negative for HPV DNA by polymerase chain reaction (PCR) for the corresponding HPV type at months 0 and 6.

Secondary

Determine the duration of protection against HPV 16 or HPV 18 cervical infection in participants treated with the HPV 16/18 L1 VLP/AS04 vaccine.
Determine the safety of this vaccine in these participants, regardless of their initial HPV 16/18 DNA status.
Evaluate the efficacy of the candidate vaccine, HPV 16/18 L1 VLP/AS04 vaccine compared with control in preventing CIN2+ associated with any oncogenic HPV type cervical infection in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6.
Compare the efficacy of the candidate vaccine with control in preventing CIN2+ associated with HPV 16 or HPV 18 cervical infection, detected within the lesional component of the cervical tissue specimen by PCR, in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6 and by enzyme-linked immunosorbent assay (ELISA) at month 0.
Compare the efficacy of the candidate vaccine with control in preventing persistent HPV 16 or HPV 18 cervical infection in these participants.
Determine the immunogenicity of HPV 16/18 L1 VLP/AS04 vaccine by ELISA and V5/J4 monoclonal antibody inhibition enzyme immunoassay in the first 600 participants randomized to receive HPV 16/18 L1 VLP/AS04 vaccine.

OUTLINE: This is a randomized, controlled, double-blind, parallel-group study. Participants are randomized to 1 of 2 treatment arms.

Arm I: Participants receive human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine intramuscularly (IM) once in months 0, 1, and 6.
Arm II: Participants receive hepatitis A vaccine (Havrix®) IM once in months 0, 1, and 6.

After completion of study treatment, participants are followed at 6 months and then at least annually for 3 years.

PROJECTED ACCRUAL: Approximately 7,500 participants will be accrued for this study.

Conditions: Cervical Cancer, Precancerous Condition
Being tested: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine, hepatitis A inactivated virus vaccine
Keywords: cervical intraepithelial neoplasia grade 2, cervical cancer, cervical intraepithelial neoplasia grade 3
Medical subject headings: Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

human papillomavirus 16/18 L1 virus-like particle/AS04 vaccineBiological
Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule
hepatitis A inactivated virus vaccineBiological
Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule

Study groups in NCT00128661
Study group	Role	What they receive
Cervarix Group	Experimental	Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine
Havrix Group	Active comparator	Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: hepatitis A inactivated virus vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.
CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.
Measured: From Month 6 up to Month 48

Secondary outcomes (19)

Number of Cervical Infection With HPV16 or HPV18.
Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Measured: From Month 6 up to Month 48
Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen. Note: The assay did not distinguish between HPV types 68 and 73. CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Measured: From Month 6 up to Month 48
Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases
Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type. Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months. Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type.
Measured: From Month 6 up to Month 48
Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.
Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination. Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)
Measured: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort
Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).
Measured: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)
Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).
Measured: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)
Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).
Measured: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Measured: Within 60 minutes after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.
Measured: Within 60 minutes after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Measured: From Day 3 to Day 6 after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.
Measured: From Day 3 to Day 6 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: During the entire study period (From Month 0 up to Month 48).
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the entire study period (From Month 0 up to Month 48).
Number of Subjects With All Possible Pregnancy Outcomes
The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.
Measured: During the entire study period (From Month 0 up to Month 48).
Number of Cervical Infection With HPV16 or HPV18.
Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Measured: During the first year of follow-up period
Number of Cervical Infection With HPV16 or HPV18.
Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Measured: During the second year of follow-up period
Number of Cervical Infection With HPV16 or HPV18.
Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Measured: During the third year of follow-up period
Number of Cervical Infection With HPV16 or HPV18.
Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Measured: From the fourth year follow-up period
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: within 30 days (Days 0-29) after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 200431 Dec 2010

First posted10 Aug 2005 (estimated)
Study start30 Jun 2004
Primary completion31 Dec 2010
Study completion31 Dec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 7,466 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00128661
Sponsor's protocol ID: CDR0000441189
Other IDs: NCI-04-C-N191, NCI-590299/009, GSK-590299/009
Status last verified: Feb 2019
First submitted: 8 Aug 2005
Last updated: 8 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Kreimer AR, Rodriguez AC, Hildesheim A, Herrero R, Porras C, Schiffman M, Gonzalez P, Solomon D, Jimenez S, Schiller JT, Lowy DR, Quint W, Sherman ME, Schussler J, Wacholder S; CVT Vaccine Group. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst. 2011 Oct 5;103(19):1444-51. doi: 10.1093/jnci/djr319. Epub 2011 Sep 9.
PubMed 21908768
Kemp TJ, Hildesheim A, Safaeian M, Dauner JG, Pan Y, Porras C, Schiller JT, Lowy DR, Herrero R, Pinto LA. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine. 2011 Mar 3;29(11):2011-4. doi: 10.1016/j.vaccine.2011.01.001. Epub 2011 Jan 15.
PubMed 21241731
Kim K, Porras C, Kreimer AR, Hempel H, Kemp TJ, Lowy DR, Pinto LA. Development of HPV 35 serology assays for assessment of immune responses to HPV 35 after infection and vaccination. Hum Vaccin Immunother. 2026 Dec;22(1):2610897. doi: 10.1080/21645515.2025.2610897. Epub 2026 Jan 27.
PubMed 41591792
Sierra MS, Coto C, Porras C, Herrero R, Ugalde D, Sauer AN, Mora D, Montes CP, Schussler J, Hoffman AC, Hicks B, Ruggieri D, Cortes B, Hildesheim A, Kreimer AR, Wentzensen N, Dagnall C, Liu D. Validation of TypeSeq2, a Next-Generation-Based Sequencing Assay for the Detection of 46 Human Papillomavirus Genotypes, at the US National Cancer Institute and Costa Rica Laboratories. J Infect Dis. 2025 Dec 20;232(6):e906-e915. doi: 10.1093/infdis/jiaf369.
PubMed 40796225
Sierra MS, Carvajal LJ, Dull P, Herrero R, Schussler J, Hildesheim A, Schiller JT, Ocampo R, Liu D, Kreimer AR, Rodriguez AC, Lowy DR, Porras C; Costa Rica HPV Vaccine Trial (CVT) Group. Human papillomavirus type 16 and 18 viral clearance and progression to precancer among women aged 18-25 years enrolled in the Costa Rica HPV prophylactic vaccine trial (CVT). Vaccine. 2025 Mar 19;50:126841. doi: 10.1016/j.vaccine.2025.126841. Epub 2025 Feb 16.
PubMed 39961279
Befano B, Campos NG, Egemen D, Herrero R, Schiffman M, Porras C, Lowy DR, Rodriguez AC, Schiller JT, Ocampo R, Hildesheim A, Sampson JN, Das S, Kreimer AR, Cheung LC; Costa Rica HPV Vaccine Trial (CVT) Group. Estimating human papillomavirus vaccine efficacy from a single-arm trial: proof-of-principle in the Costa Rica Vaccine Trial. J Natl Cancer Inst. 2023 Jul 6;115(7):788-795. doi: 10.1093/jnci/djad064.
PubMed 37040086
Sierra MS, Tsang SH, Porras C, Herrero R, Sampson JN, Cortes B, Schussler J, Wagner S, Carvajal L, Quint W, Kreimer AR, Hu S, Rodriguez AC, Romero B, Hildesheim A; Costa Rica HPV Vaccine Trial (CVT) Group. Analysis of cervical HPV infections among unvaccinated young adult women to inform vaccine strategies in this age group: the Costa Rica HPV Vaccine Trial. Sex Transm Infect. 2022 Jul 16;99(3):180-6. doi: 10.1136/sextrans-2022-055434. Online ahead of print.
PubMed 35842229
Shing JZ, Hu S, Herrero R, Hildesheim A, Porras C, Sampson JN, Schussler J, Schiller JT, Lowy DR, Sierra MS, Carvajal L, Kreimer AR; Costa Rica HPV Vaccine Trial Group. Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol. 2022 Jul;23(7):940-949. doi: 10.1016/S1470-2045(22)00291-1. Epub 2022 Jun 13.
PubMed 35709811
Usyk M, Schlecht NF, Pickering S, Williams L, Sollecito CC, Gradissimo A, Porras C, Safaeian M, Pinto L, Herrero R, Strickler HD, Viswanathan S, Nucci-Sack A, Diaz A; Costa Rica HPV Vaccine Trial (CVT) Group; Burk RD. molBV reveals immune landscape of bacterial vaginosis and predicts human papillomavirus infection natural history. Nat Commun. 2022 Jan 11;13(1):233. doi: 10.1038/s41467-021-27628-3.
PubMed 35017496
Usyk M, Zolnik CP, Castle PE, Porras C, Herrero R, Gradissimo A, Gonzalez P, Safaeian M, Schiffman M, Burk RD; Costa Rica HPV Vaccine Trial (CVT) Group. Cervicovaginal microbiome and natural history of HPV in a longitudinal study. PLoS Pathog. 2020 Mar 26;16(3):e1008376. doi: 10.1371/journal.ppat.1008376. eCollection 2020 Mar.
PubMed 32214382
Safaeian M, Castellsague X, Hildesheim A, Wacholder S, Schiffman MH, Bozonnat MC, Baril L, Rosillon D; Costa Rica HPV Vaccine Trial and the PATRICIA study groups. Risk of HPV-16/18 Infections and Associated Cervical Abnormalities in Women Seropositive for Naturally Acquired Antibodies: Pooled Analysis Based on Control Arms of Two Large Clinical Trials. J Infect Dis. 2018 Jun 5;218(1):84-94. doi: 10.1093/infdis/jiy112.
PubMed 29718393
Hildesheim A, Gonzalez P, Kreimer AR, Wacholder S, Schussler J, Rodriguez AC, Porras C, Schiffman M, Sidawy M, Schiller JT, Lowy DR, Herrero R; Costa Rica HPV Vaccine Trial (CVT) Group. Impact of human papillomavirus (HPV) 16 and 18 vaccination on prevalent infections and rates of cervical lesions after excisional treatment. Am J Obstet Gynecol. 2016 Aug;215(2):212.e1-212.e15. doi: 10.1016/j.ajog.2016.02.021. Epub 2016 Feb 16.
PubMed 26892991
Beachler DC, Kreimer AR, Schiffman M, Herrero R, Wacholder S, Rodriguez AC, Lowy DR, Porras C, Schiller JT, Quint W, Jimenez S, Safaeian M, Struijk L, Schussler J, Hildesheim A, Gonzalez P; Costa Rica HPV Vaccine Trial (CVT) Group. Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection. J Natl Cancer Inst. 2015 Oct 14;108(1):djv302. doi: 10.1093/jnci/djv302. Print 2016 Jan.
PubMed 26467666
Panagiotou OA, Befano BL, Gonzalez P, Rodriguez AC, Herrero R, Schiller JT, Kreimer AR, Schiffman M, Hildesheim A, Wilcox AJ, Wacholder S; Costa Rica HPV Vaccine Trial (CVT) Group (see end of manuscript for full list of investigators). Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial. BMJ. 2015 Sep 7;351:h4358. doi: 10.1136/bmj.h4358.
PubMed 26346155
Kreimer AR, Struyf F, Del Rosario-Raymundo MR, Hildesheim A, Skinner SR, Wacholder S, Garland SM, Herrero R, David MP, Wheeler CM; Costa Rica Vaccine Trial Study Group Authors; Gonzalez P, Jimenez S, Lowy DR, Pinto LA, Porras C, Rodriguez AC, Safaeian M, Schiffman M, Schiller JT, Schussler J, Sherman ME; PATRICIA Study Group Authors; Bosch FX, Castellsague X, Chatterjee A, Chow SN, Descamps D, Diaz-Mitoma F, Dubin G, Germar MJ, Harper DM, Lewis DJ, Limson G, Naud P, Peters K, Poppe WA, Ramjattan B, Romanowski B, Salmeron J, Schwarz TF, Teixeira JC, Tjalma WA; HPV PATRICIA Principal Investigators/Co-Principal Investigator Collaborators; GSK Vaccines Clinical Study Support Group. Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA Trials. Lancet Oncol. 2015 Jul;16(7):775-86. doi: 10.1016/S1470-2045(15)00047-9. Epub 2015 Jun 9.
PubMed 26071347

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.
ClinicalTrials.gov ID: NCT00128661
Acronym / sponsor ID: CDR0000441189
Conditions: Cervical Cancer, Precancerous Condition
Keywords: cervical intraepithelial neoplasia grade 2, cervical cancer, cervical intraepithelial neoplasia grade 3
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 7,466 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Jun 2004 (actual)
Primary completion: 31 Dec 2010 (actual)
Study completion: 31 Dec 2010 (actual)
First posted: 10 Aug 2005 (estimated)
Results: Posted 2 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

Secondary

Determine the duration of protection against HPV 16 or HPV 18 cervical infection in participants treated with the HPV 16/18 L1 VLP/AS04 vaccine.
Determine the safety of this vaccine in these participants, regardless of their initial HPV 16/18 DNA status.
Evaluate the efficacy of the candidate vaccine, HPV 16/18 L1 VLP/AS04 vaccine compared with control in preventing CIN2+ associated with any oncogenic HPV type cervical infection in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6.
Compare the efficacy of the candidate vaccine with control in preventing CIN2+ associated with HPV 16 or HPV 18 cervical infection, detected within the lesional component of the cervical tissue specimen by PCR, in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6 and by enzyme-linked immunosorbent assay (ELISA) at month 0.
Compare the efficacy of the candidate vaccine with control in preventing persistent HPV 16 or HPV 18 cervical infection in these participants.
Determine the immunogenicity of HPV 16/18 L1 VLP/AS04 vaccine by ELISA and V5/J4 monoclonal antibody inhibition enzyme immunoassay in the first 600 participants randomized to receive HPV 16/18 L1 VLP/AS04 vaccine.

OUTLINE: This is a randomized, controlled, double-blind, parallel-group study. Participants are randomized to 1 of 2 treatment arms.

Arm I: Participants receive human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine intramuscularly (IM) once in months 0, 1, and 6.
Arm II: Participants receive hepatitis A vaccine (Havrix®) IM once in months 0, 1, and 6.

After completion of study treatment, participants are followed at 6 months and then at least annually for 3 years.

PROJECTED ACCRUAL: Approximately 7,500 participants will be accrued for this study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cervarix Group	Experimental	Biological: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccineSubjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group	Active comparator	Biological: hepatitis A inactivated virus vaccineSubjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Who may qualify

Ages: 18 to 25 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
human papillomavirus 16/18 L1 virus-like particle/AS04 vaccineThree doses of Cervarix vaccine administered on a 0, 1, 6-month schedule	Biological	Cervarix Group
hepatitis A inactivated virus vaccineThree doses of Havrix vaccine administered on a 0, 1, 6-month schedule	Biological	Havrix Group

Primary outcome

Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.
Time frame: From Month 6 up to Month 48
CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.

19 secondary outcomes

Number of Cervical Infection With HPV16 or HPV18.
Time frame: From Month 6 up to Month 48
Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type
Time frame: From Month 6 up to Month 48
Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases
Time frame: From Month 6 up to Month 48
Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.
Time frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort
Time frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)
Time frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)
Time frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Time frame: Within 60 minutes after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Time frame: Within 60 minutes after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.
Time frame: From Day 3 to Day 6 after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.
Time frame: From Day 3 to Day 6 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).
Time frame: During the entire study period (From Month 0 up to Month 48).
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Time frame: During the entire study period (From Month 0 up to Month 48).
Number of Subjects With All Possible Pregnancy Outcomes
Time frame: During the entire study period (From Month 0 up to Month 48).
Number of Cervical Infection With HPV16 or HPV18.
Time frame: During the first year of follow-up period
Number of Cervical Infection With HPV16 or HPV18.
Time frame: During the second year of follow-up period
Number of Cervical Infection With HPV16 or HPV18.
Time frame: During the third year of follow-up period
Number of Cervical Infection With HPV16 or HPV18.
Time frame: From the fourth year follow-up period
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Time frame: within 30 days (Days 0-29) after vaccination

Results and safety

Results posted to the registry on 2 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cervarix Group	3,727	3,453
Havrix Group	3,739	3,481

Primary outcome: Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.

Time frame: From Month 6 up to Month 48. Number. Unit: Events

Measure	Cervarix Group n = 2635	Havrix Group n = 2677
HPV16 Associated CIN2+ (N=2464;2452)	1	9
HPV18 Associated CIN2+ (N=2567; 2593)	0	2
HPV16 and/or 18 Associated CIN2+ (N=2635;2677)	1	10

Population analysed: The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: within 60 minutes after vaccination for all participants [please refer to Participant Flow Pre-assignment Details for population description]; From Day 3 to Day 6 post-vaccination for a 10% random subset of participants. SAEs: From Month 0 up to Month 48. Unsolicited AEs: From Month 0 up to Month 48 and Within 30 days (Days 0-29) after vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	912 of 3,727 (24.5%)	1,627 of 3,730 (43.6%)	Not reported
Havrix Group	891 of 3,739 (23.8%)	1,610 of 3,740 (43%)	Not reported

Limitations and caveats (from the sponsor): The following analysis "occurence of histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection was not performed, in accordance with the Statistical Analysis Plan submitted to the FDA.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21908768Kreimer AR, Rodriguez AC, Hildesheim A, Herrero R, Porras C, Schiffman M, Gonzalez P, Solomon D, Jimenez S, Schiller JT, Lowy DR, Quint W, Sherman ME, Schussler J, Wacholder S; CVT Vaccine Group. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst. 2011 Oct 5;103(19):1444-51. doi: 10.1093/jnci/djr319. Epub 2011 Sep 9.
Background: PubMed 21241731Kemp TJ, Hildesheim A, Safaeian M, Dauner JG, Pan Y, Porras C, Schiller JT, Lowy DR, Herrero R, Pinto LA. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine. 2011 Mar 3;29(11):2011-4. doi: 10.1016/j.vaccine.2011.01.001. Epub 2011 Jan 15.
Derived from this study: PubMed 41591792Kim K, Porras C, Kreimer AR, Hempel H, Kemp TJ, Lowy DR, Pinto LA. Development of HPV 35 serology assays for assessment of immune responses to HPV 35 after infection and vaccination. Hum Vaccin Immunother. 2026 Dec;22(1):2610897. doi: 10.1080/21645515.2025.2610897. Epub 2026 Jan 27.
Derived from this study: PubMed 40796225Sierra MS, Coto C, Porras C, Herrero R, Ugalde D, Sauer AN, Mora D, Montes CP, Schussler J, Hoffman AC, Hicks B, Ruggieri D, Cortes B, Hildesheim A, Kreimer AR, Wentzensen N, Dagnall C, Liu D. Validation of TypeSeq2, a Next-Generation-Based Sequencing Assay for the Detection of 46 Human Papillomavirus Genotypes, at the US National Cancer Institute and Costa Rica Laboratories. J Infect Dis. 2025 Dec 20;232(6):e906-e915. doi: 10.1093/infdis/jiaf369.
Derived from this study: PubMed 39961279Sierra MS, Carvajal LJ, Dull P, Herrero R, Schussler J, Hildesheim A, Schiller JT, Ocampo R, Liu D, Kreimer AR, Rodriguez AC, Lowy DR, Porras C; Costa Rica HPV Vaccine Trial (CVT) Group. Human papillomavirus type 16 and 18 viral clearance and progression to precancer among women aged 18-25 years enrolled in the Costa Rica HPV prophylactic vaccine trial (CVT). Vaccine. 2025 Mar 19;50:126841. doi: 10.1016/j.vaccine.2025.126841. Epub 2025 Feb 16.
Derived from this study: PubMed 37040086Befano B, Campos NG, Egemen D, Herrero R, Schiffman M, Porras C, Lowy DR, Rodriguez AC, Schiller JT, Ocampo R, Hildesheim A, Sampson JN, Das S, Kreimer AR, Cheung LC; Costa Rica HPV Vaccine Trial (CVT) Group. Estimating human papillomavirus vaccine efficacy from a single-arm trial: proof-of-principle in the Costa Rica Vaccine Trial. J Natl Cancer Inst. 2023 Jul 6;115(7):788-795. doi: 10.1093/jnci/djad064.
Derived from this study: PubMed 35842229Sierra MS, Tsang SH, Porras C, Herrero R, Sampson JN, Cortes B, Schussler J, Wagner S, Carvajal L, Quint W, Kreimer AR, Hu S, Rodriguez AC, Romero B, Hildesheim A; Costa Rica HPV Vaccine Trial (CVT) Group. Analysis of cervical HPV infections among unvaccinated young adult women to inform vaccine strategies in this age group: the Costa Rica HPV Vaccine Trial. Sex Transm Infect. 2022 Jul 16;99(3):180-6. doi: 10.1136/sextrans-2022-055434. Online ahead of print.
Derived from this study: PubMed 35709811Shing JZ, Hu S, Herrero R, Hildesheim A, Porras C, Sampson JN, Schussler J, Schiller JT, Lowy DR, Sierra MS, Carvajal L, Kreimer AR; Costa Rica HPV Vaccine Trial Group. Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol. 2022 Jul;23(7):940-949. doi: 10.1016/S1470-2045(22)00291-1. Epub 2022 Jun 13.
Derived from this study: PubMed 35017496Usyk M, Schlecht NF, Pickering S, Williams L, Sollecito CC, Gradissimo A, Porras C, Safaeian M, Pinto L, Herrero R, Strickler HD, Viswanathan S, Nucci-Sack A, Diaz A; Costa Rica HPV Vaccine Trial (CVT) Group; Burk RD. molBV reveals immune landscape of bacterial vaginosis and predicts human papillomavirus infection natural history. Nat Commun. 2022 Jan 11;13(1):233. doi: 10.1038/s41467-021-27628-3.
Derived from this study: PubMed 32214382Usyk M, Zolnik CP, Castle PE, Porras C, Herrero R, Gradissimo A, Gonzalez P, Safaeian M, Schiffman M, Burk RD; Costa Rica HPV Vaccine Trial (CVT) Group. Cervicovaginal microbiome and natural history of HPV in a longitudinal study. PLoS Pathog. 2020 Mar 26;16(3):e1008376. doi: 10.1371/journal.ppat.1008376. eCollection 2020 Mar.
Derived from this study: PubMed 29718393Safaeian M, Castellsague X, Hildesheim A, Wacholder S, Schiffman MH, Bozonnat MC, Baril L, Rosillon D; Costa Rica HPV Vaccine Trial and the PATRICIA study groups. Risk of HPV-16/18 Infections and Associated Cervical Abnormalities in Women Seropositive for Naturally Acquired Antibodies: Pooled Analysis Based on Control Arms of Two Large Clinical Trials. J Infect Dis. 2018 Jun 5;218(1):84-94. doi: 10.1093/infdis/jiy112.
Derived from this study: PubMed 26892991Hildesheim A, Gonzalez P, Kreimer AR, Wacholder S, Schussler J, Rodriguez AC, Porras C, Schiffman M, Sidawy M, Schiller JT, Lowy DR, Herrero R; Costa Rica HPV Vaccine Trial (CVT) Group. Impact of human papillomavirus (HPV) 16 and 18 vaccination on prevalent infections and rates of cervical lesions after excisional treatment. Am J Obstet Gynecol. 2016 Aug;215(2):212.e1-212.e15. doi: 10.1016/j.ajog.2016.02.021. Epub 2016 Feb 16.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. (time frame: From Month 6 up to Month 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00128661, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.